Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study. (DEFINE-TAVR)

August 5, 2025 updated by: Yale University

DEFINE-TAVR (Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement) Study

The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:

  • Describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after TAVR implantation to define valve function and hemodynamics over time.
  • Compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.

Description

Inclusion Criteria:

  • Male or non-pregnant female ≥18 years of age
  • Clinically indicated for TAVR
  • Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)
  • Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography
  • Willing to comply with protocol-specified follow-up evaluations
  • The participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

  • Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)
  • Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
  • Left ventricular ejection fraction (LVEF) <35%
  • Presenting with cardiogenic shock at the time of the index procedure
  • Planned to undergo any cardiac surgical procedure in the following 12 months
  • The index procedure results in an unsuccessful TAVR, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TransAortic Valve Gradient during exercise at 12 months post-TAVR
Time Frame: 12 months post-TAVR
TransAortic Valve Gradient (mmHg) during exercise as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean.
12 months post-TAVR

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in valve cusp thickness at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in valve cusp thickness (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in valve mobility at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in valve mobility at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in paravalvular leak at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in paravalvular leak at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coefficient of contraction EOA/GOA at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Dimensionless Velocity Index (DVI) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in DVI at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in energy loss coefficient at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in EOA at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in EOA (cm2) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (mmHg) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve velocity (m/s) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Left Ventricle (LV) remodeling at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV remodeling at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in leaflet thickening at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in leaflet thickening at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coaptation length at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coaptation length (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV thickness at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV thickness (cm) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV Global Longitudinal Strain at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV Global Longitudinal Strain (%) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Right Ventricular (RV) systolic velocity at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in RV systolic velocity (cm/s) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in RV systolic pressure (RVSP) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in RVSP (mmHg) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest
Time Frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in TAPSE (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) with exercise
Time Frame: 30 days, and 12 months post-TAVR
Change in gradient (mmHg) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) with exercise
Time Frame: 30 days and 12 months post-TAVR
Change in aortic valve velocity (m/s) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days and 12 months post-TAVR
Change in DVI with exercise
Time Frame: 30 days and 12 months post-TAVR
Change in DVI with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days and 12 months post-TAVR
Change in EOA with exercise
Time Frame: 30 days and 12 months post-TAVR
Change in EOA (cm2) with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days and 12 months post-TAVR
Change in RVSP with exercise
Time Frame: 30 days and 12 months post-TAVR
Change in RVSP (mmHg) with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days and 12 months post-TAVR
Change in exercise duration
Time Frame: 30 days and 12 months post-TAVR
Change in exercise duration (min) reported as absolute values and as changes.
30 days and 12 months post-TAVR
Change in LV Global Longitudinal Strain with exercise
Time Frame: 30 days and 12 months post-TAVR
Change in LV Global Longitudinal Strain (%) with exercise assessed using echocardiogram reported as absolute values and as changes.
30 days and 12 months post-TAVR
TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)
Time Frame: during hospitalization approximatively 3 days
TAVR Device Success evaluated post-procedure/pre-discharge during hospitalization approximatively 3 days, defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (defined as no prosthesis-patient mismatch [VARC-defined] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation [VARC-defined] [site and Core Laboratory-reported].
during hospitalization approximatively 3 days
Composite Safety Endpoints (VARC-3 defined)
Time Frame: 30 days and 12 months post-TAVR
Composite safety endpoint reported as a proportion of participants who died or experienced neurological events or life-threatening bleeding or acute kidney injury or coronary artery obstruction requiring intervention or major vascular complications or valve-related dysfunction requiring repeat procedure evaluated at 30 days and 12 months.
30 days and 12 months post-TAVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anteris Technologies Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alexandra J Lansky, MD, Yale University
  • Principal Investigator: Amit Vora, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000033211
  • YSI-002 (Other Identifier: Yale)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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